10,380
Views
16
CrossRef citations to date
0
Altmetric
Reports

Linear pharmacokinetic parameters for monoclonal antibodies are similar within a species and across different pharmacological targets: A comparison between human, cynomolgus monkey and hFcRn Tg32 transgenic mouse using a population-modeling approach

, ORCID Icon, , , ORCID Icon, & show all
Pages 751-764 | Received 12 Feb 2018, Accepted 03 Apr 2018, Published online: 14 May 2018

References

  • Mould DR, Meibohm B. Drug development of therapeutic monoclonal antibodies. BioDrugs. 2016;30:275–93. doi:10.1007/s40259-016-0181-6. PMID:27342605.
  • Ryman JT, Meibohm B. Pharmacokinetics of monoclonal antibodies. CPT Pharmacometrics Syst Pharmacol. 2017;6:576–88. doi:10.1002/psp4.12224. PMID:28653357.
  • Tabrizi MA, Tseng CM, Roskos LK. Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discov Today. 2006;11:81–8. doi:10.1016/S1359-6446(05)03638-X. PMID:16478695.
  • Junghans RP, Anderson CL. The protection receptor for IgG catabolism is the beta2-microglobulin-containing neonatal intestinal transport receptor. Proc Natl Acad Sci U S A. 1996;93:5512–6. doi:10.1073/pnas.93.11.5512. PMID:8643606.
  • Betts AM, Clark TH, Yang J, Treadway JL, Li M, Giovanelli MA, Abdiche Y, Stone DM, Paralkar VM. The application of target information and preclinical pharmacokinetic/pharmacodynamic modeling in predicting clinical doses of a Dickkopf-1 antibody for osteoporosis. J Pharmacol Exp Ther. 2010;333:2–13. doi:10.1124/jpet.109.164129. PMID:20089807.
  • Baxter LT, Zhu H, Mackensen DG, Jain RK. Physiologically based pharmacokinetic model for specific and nonspecific monoclonal antibodies and fragments in normal tissues and human tumor xenografts in nude mice. Cancer Res. 1994;54:1517–28. PMID:8137258.
  • Ferl GZ, Wu AM, DiStefano JJ, 3rd. A predictive model of therapeutic monoclonal antibody dynamics and regulation by the neonatal Fc receptor (FcRn). Ann Biomed Eng. 2005;33:1640–52. doi:10.1007/s10439-005-7410-3. PMID:16341929.
  • Lobo ED, Hansen RJ, Balthasar JP. Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci. 2004;93:2645–68. doi:10.1002/jps.20178. PMID:15389672.
  • Wang W, Wang EQ, Balthasar JP. Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther. 2008;84:548–58. doi:10.1038/clpt.2008.170. PMID:18784655.
  • Neuber T, Frese K, Jaehrling J, Jäger S, Daubert D, Felderer K, Linnemann M, Höhne A, Kaden S, Kölln J, et al. Characterization and screening of IgG binding to the neonatal Fc receptor. MAbs. 2014;6:928–42. doi:10.4161/mabs.28744. PMID:24802048.
  • Deng R, Iyer S, Theil F-P, Mortensen DL, Fielder PJ, Prabhu S. Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data. mAbs. 2014;3:61–6. doi:10.4161/mabs.3.1.13799.
  • Dong JQ, Salinger DH, Endres CJ, Gibbs JP, Hsu CP, Stouch BJ, Hurh E, Gibbs MA. Quantitative prediction of human pharmacokinetics for monoclonal antibodies: Retrospective analysis of monkey as a single species for first-in-human prediction. Clin Pharmacokinet. 2011;50:131–42. doi:10.2165/11537430-000000000-00000. PMID:21241072.
  • Ling J, Zhou H, Jiao Q, Davis HM. Interspecies scaling of therapeutic monoclonal antibodies: initial look. J Clin Pharmacol. 2009;49:1382–402. doi:10.1177/0091270009337134. PMID:19837907.
  • Oitate M, Masubuchi N, Ito T, Yabe Y, Karibe T, Aoki T, Murayama N, Kurihara A, Okudaira N, Izumi T. Prediction of Human Pharmacokinetics of Therapeutic Monoclonal Antibodies from Simple Allometry of Monkey Data. Drug Metab Pharmacokinet. 2011;26:423–30. doi:10.2133/dmpk.DMPK-11-RG-011. PMID:21606605.
  • Dua P, Hawkins E, van der Graaf PH. A Tutorial on Target-Mediated Drug Disposition (TMDD) Models. CPT Pharmacometrics Syst Pharmacol. 2015;4:324–37. doi:10.1002/psp4.41. PMID:26225261.
  • Mager DE, Jusko WJ. General pharmacokinetic model for drugs exhibiting target-mediated drug disposition. J Pharmacokinet Pharmacodyn. 2001;28:507–32. doi:10.1023/A:1014414520282. PMID:11999290.
  • Singh AP, Krzyzanski W, Martin SW, Weber G, Betts A, Ahmad A, Abraham A, Zutshi A, Lin J, Singh P. Quantitative prediction of human pharmacokinetics for mAbs exhibiting target-mediated disposition. AAPS J. 2015;17:389–99. doi:10.1208/s12248-014-9690-8. PMID:25445845.
  • Ette EI, Williams PJ. Population pharmacokinetics I: background, concepts, and models. Ann Pharmacother. 2004;38:1702–6. doi:10.1345/aph.1D374. PMID:15328391.
  • Dirks NL, Meibohm B. Population pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010;49:633–59. doi:10.2165/11535960-000000000-00000. PMID:20818831.
  • Waldmann TA, Strober W. Metabolism of immunoglobulins. Prog Allergy. 1969;13:1–110. PMID:4186070.
  • Liu Y, Caffry I, Wu J, Geng SB, Jain T, Sun T, Reid F, Cao Y, Estep P, Yu Y, et al. High-throughput screening for developability during early-stage antibody discovery using self-interaction nanoparticle spectroscopy. MAbs. 2014;6:483–92. doi:10.4161/mabs.27431. PMID:24492294.
  • Ober RJ, Radu CG, Ghetie V, Ward ES. Differences in promiscuity for antibody-FcRn interactions across species: implications for therapeutic antibodies. Int Immunol. 2001;13:1551–9. doi:10.1093/intimm/13.12.1551. PMID:11717196.
  • Avery LB, Wang M, Kavosi MS, Joyce A, Kurz JC, Fan YY, Dowty ME, Zhang M, Zhang Y, Cheng A, et al. Utility of a human FcRn transgenic mouse model in drug discovery for early assessment and prediction of human pharmacokinetics of monoclonal antibodies. MAbs. 2016;8:1064–78. doi:10.1080/19420862.2016.1193660. PMID:27232760.
  • Roopenian DC, Christianson GJ, Sproule TJ. Human FcRn transgenic mice for pharmacokinetic evaluation of therapeutic antibodies. Methods Mol Biol. 2010;602:93–104. doi:10.1007/978-1-60761-058-8_6. PMID:20012394.
  • Davda JP, Dodds MG, Gibbs MA, Wisdom W, Gibbs J. A model-based meta-analysis of monoclonal antibody pharmacokinetics to guide optimal first-in-human study design. MAbs. 2014;6:1094–102. doi:10.4161/mabs.29095. PMID:24837591.
  • Bai S, Jorga K, Xin Y, Jin D, Zheng Y, Damico-Beyer LA, Gupta M, Tang M, Allison DE, Lu D, et al. A guide to rational dosing of monoclonal antibodies. Clin Pharmacokinet. 2012;51:119–35. doi:10.2165/11596370-000000000-00000. PMID:22257150.
  • Wang DD, Zhang S, Zhao H, Men AY, Parivar K. Fixed dosing versus body size-based dosing of monoclonal antibodies in adult clinical trials. J Clin Pharmacol. 2009;49:1012–24. doi:10.1177/0091270009337512. PMID:19620385.
  • Gill KL, Gardner I, Li L, Jamei M. A Bottom-Up Whole-Body Physiologically Based Pharmacokinetic Model to Mechanistically Predict Tissue Distribution and the Rate of Subcutaneous Absorption of Therapeutic Proteins. AAPS J. 2016;18:156–70. doi:10.1208/s12248-015-9819-4. PMID:26408308.
  • Feagan BG, Choquette D, Ghosh S, Gladman DD, Ho V, Meibohm B, Zou G, Xu Z, Shankar G, Sealey DC, et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals. 2014;42:177–83. doi:10.1016/j.biologicals.2014.05.005. PMID:24962198.
  • Hotzel I, Theil FP, Bernstein LJ, Prabhu S, Deng R, Quintana L, Lutman J, Sibia R, Chan P, Bumbaca D, et al. A strategy for risk mitigation of antibodies with fast clearance. MAbs. 2012;4:753–60. doi:10.4161/mabs.22189. PMID:23778268.
  • Notkins AL. Polyreactivity of antibody molecules. Trends Immunol. 2004;25:174–9. doi:10.1016/j.it.2004.02.004. PMID:15039043.
  • Avery LB, Wade J, Wang M, Tam A, King A, Piche-Nicholas N, Kavosi MS, Penn S, Cirelli D, Kurz JC, et al. Establishing in vitro in vivo correlations to screen monoclonal antibodies for physicochemical properties related to favorable human pharmacokinetics. MAbs. 2018:10.
  • Hosea NA, Collard WT, Cole S, Maurer TS, Fang RX, Jones H, Kakar SM, Nakai Y, Smith BJ, Webster R, et al. Prediction of human pharmacokinetics from preclinical information: comparative accuracy of quantitative prediction approaches. J Clin Pharmacol. 2009;49:513–33. doi:10.1177/0091270009333209. PMID:19299532.
  • Tang H, Hussain A, Leal M, Mayersohn M, Fluhler E. Interspecies prediction of human drug clearance based on scaling data from one or two animal species. Drug metabolism and disposition: The biological fate of chemicals. 2007;35:1886–93. doi:10.1124/dmd.107.016188. PMID:17646280.
  • Russell WMSB RL. The principles of humane experimental technique. London: Methuen; 1959.
  • Beal S SL, Boeckmann A, Bauer RJ. NONMEM user's guides. Ellicott City (MD, USA): ICON Development Solutions; 1989–2009.
  • Lindbom L, Pihlgren P, Jonsson EN. PsN-Toolkit–a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. Comput Methods Programs Biomed. 2005;79:241–57. doi:10.1016/j.cmpb.2005.04.005. PMID:16023764.